Network meta-analysis of probiotics, prebiotics, and synbiotics for the treatment of chronic constipation in adults.

OBJECTIVE: To compare the outcomes associated with the use of probiotics, prebiotics, and synbiotics for the treatment of chronic constipation in adults. METHODS: We searched eight electronic databases from database inception to July 11, 2023, to identify randomized controlled trials (RCTs) that report efficacy and safety for the treatment of chronic constipation. The risk of bias in the included RCTs was evaluated according to the Cochrane tool, and the certainty of the evidence was assessed using the Confidence in Network Meta-Analysis framework. The analysis was conducted using R version 4.3.0. RESULTS: Out of the 37 RCTs, a total of 21 different types of interventions were reported, involving 3,903 patients. This NMA demonstrated that both prebiotics and synbiotics resulted in an increase in frequency of stool movements per week. Compared to placebo, lactulose (Mean difference [MD] = 3.39, 95% Confdence interval [CI] [1.13, 5.65], moderate certainty), mix2 (consisting of Lactulose and Bacillus coagulans) (MD = 3.63, 95% CI [1.37, 5.89], moderate certainty), mix6 (consisting of Lactulose and Bifidobacterium coagulans) (MD = 4.30, 95% CI [1.04, 7.54], low certainty), and mix7 (consisting of Lactulose, Bifidobacterium subtilis, and Enterococcus faecium) (MD = 4.58, 95% CI [1.35, 7.78], moderate certainty) exhibited a significant effect. Notably, mix7 demonstrated the highest probability of being the most effective intervention (94.8%). Furthermore, when compared to L. plantarum, four probiotics and two synbiotics showed significant advantages in the Patient Assessment of Constipation Symptoms (PAC-SYM) score. L. reuteri (MD = -13.74, 95% CI [-22.20, -4.66], very low certainty) exhibited a significant effect in improving the Patient Assessment of Constipation Quality of Life (PAC-QoL) score. In terms of safety, there were no statistically significant differences between the intervention and control groups in all adverse event analyses. CONCLUSIONS: Moderate to very low evidence supports the use of lactulose and synbiotics to increase the number of weekly stool movements in patients, particularly highlighting the significant impact of synbiotics in increasing the number of weekly stool movements in patients with constipation. The use of L. paracasei showed improvements in PAC-SYM scores, while L. reuteri demonstrated enhancements in PAC-QoL scores.

Exercise modalities for type 2 diabetes: A systematic review and network meta-analysis of randomized trials.

AIMS: We aimed to determine the effects of different exercise modalities in patients with type 2 diabetes mellitus (T2DM). METHODS: We searched PubMed, Embase, and the Cochrane Library from their inception until July 2020 to identify randomised controlled trials (RCTs) on exercise in adults with T2DM. Paired reviewers independently performed study selection, data extraction, and risk of bias assessment. The certainty of the evidence was assessed using the Confidence in Network Meta-Analysis (CINeMA) framework. RESULTS: A total of 106 RCTs that enroled eight exercise modalities with 7438 patients were included. Six exercise modalities, except unsupervised aerobic/resistance exercise, significantly reduced glycosylated haemoglobin (HbA1c), with mean differences (MDs) ranging from 0.71 (95% confidence interval [CI]: 0.34-1.08) to 0.34 (95% CI: 0.17-0.52), low to high certainty, in comparison with no exercise. The evidence of low to moderate certainty showed that supervised aerobic/resistance exercise improved glycaemic control, body weight, blood pressure, and blood lipid profiles compared with no exercise. Flexibility exercise may be associated with glycaemic control (HbA1c: MD = 0.71, 95% CI: 0.34-1.08); fasting plasma glucose (MD = 1.48, 95% CI: 0.78-2.17), and weight loss (MD = 1.80, 95% CI: 0.85-2.75) compared with controls, but not blood pressure and lipid profiles. Balance exercise showed the largest benefit in improving total cholesterol (MD = 52.81, 95% CI: 28.47-77.16) and low certainty. We found no significant differences between exercises and the triacylglycerol (TG) level. CONCLUSIONS: Overall, our network meta-analyses support the recommendation for exercise in patients with T2DM, especially supervised exercises. Limited evidence supports the benefits of flexibility and balance exercises. The effectiveness of exercise modalities for TG reduction remains unclear.

PFMT relevant strategies to prevent perineal trauma: a systematic review and network meta-analysis.

BACKGROUND: Most women suffer from perineal trauma during childbirth, whether it is natural tears or episiotomy. OBJECTIVES: To perform a systematic review and network meta-analysis investigating the effectiveness of different PFMT relevant strategies in the prevention of perineal trauma. SEARCH STRATEGY: PubMed, Embase, the Cochrane Library, CINAHL, CNKI, CBM, WANFANG DATABASE, and ClinicalTrials.gov were searched for citations published in any language from inception to 1 July 2021. SELECTION CRITERIA: Randomized controlled trials (RCTs) of PFMT relevant prevention strategies for preventing perineal trauma during childbirth. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two reviewers. Relative treatment effects were estimated using network meta-analysis (NMA). MAIN RESULTS: Of 12 632 citations searched, 21 RCTs were included. Comparing with usual care, "PFMT combine with perineal massage" and PFMT alone showed more superiority in intact perineum (RR = 5.37, 95% CI: 3.79 to 7.60, moderate certainty; RR = 2.58, 95% CI 1.34-4.97, moderate certainty, respectively), episiotomy (RR = 0.26, 95% CI 0.14-0.49, very low certainty; RR = 0.63, 95% CI 0.45-0.90, very low certainty, respectively), and OASIS (RR = 0.35, 95% CI 0.16-0.78, moderate certainty; RR = 0.49, 95% CI 0.28-0.85, high certainty, respectively). "PFMT combine with perineal massage" showed superiority in reducing perineal tear (RR = 0.41, 95% CI 0.20-0.85, moderate certainty). CONCLUSIONS: In view of the results, antenatal "PFMT combine with perineal massage" and PFMT were effective strategies for the prevention of perineal trauma.

Surgical Interventions for Congenital Ptosis: a Systematic Review and Meta-analysis of 14 Randomized Controlled Trials.

BACKGROUND: Several types of surgeries have been used in the treatment of congenital ptosis, but the optimal methods and materials for this treatment are unknown. PURPOSE: The study aims to evaluate the comparative effectiveness and safety of various surgical methods and materials for treatment of congenital ptosis. METHODS: We performed comprehensive searches of five databases, two clinical trial registries and one gray literature database from inception to January 2022 for related trials to include in this study. Meta-analysis was performed to evaluate the effect of surgical methods and materials on the primary outcomes: margin reflex distance 1 (MRD1), palpebral fissure height (PFH), and degree of lagophthalmos; and secondary outcomes: undercorrection, entropion, corneal epithelial defects, wound dehiscence, recurrence, infection, and cosmetic outcomes. RESULTS: A total of 14 trials evaluating 909 eyes of 657 patients were included in our study. Compared with the levator plication, the frontalis sling significantly increased the MRD1 (MD = - 1.21; 95% CI [- 1.69, - 0.73]), and the levator resection significantly increased the PFH (MD = 1.30; 95% CI [0.27, 2.33]). For the frontalis sling surgical patterns, the fox pentagon was significantly better than the double triangle at improving the degree of lagophthalmos (MD = 0.70; 95% CI [0.32, 1.08]), while the opened pattern provided statistically better cosmetic outcome than the closed frontalis sling. Analysis of surgical material showed that absorbable sutures significantly increased the MRD1 (MD = 1.16; 95% CI [0.60, 1.72]) compared to non-absorbable sutures when used in levator plication; frontalis sling surgeries performed with silicon rods significantly increased the PFH (MD = 0.88; 95% CI [0.29, 1.47]) compared to those performed with Gore-Tex strips, while autogenous fascia lata provided statistically better aesthetic outcome for lid height symmetry and contour. CONCLUSION: Different surgical methods and materials appear to affect different aspects of the congenital ptosis treatment outcome. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Efficacy and safety of targeted drugs in advanced or metastatic gastric and gastroesophageal junction cancer: A network meta-analysis.

WHAT IS KNOWN AND OBJECTIVE: An increasing number of targeted drugs have been used to treat advanced or metastatic gastric cancer (GC) and gastroesophageal junction cancer (GEJC). However, the optimal treatment efficacy of these drugs is still controversial. The aims of this study are to systematically summarize the efficacy and safety of current targeted drugs for advanced or metastatic GC and GEJC. METHODS: PubMed, EmBase, Cochrane Library, Web of Science and ClinicalTrials were searched for double-blind randomized controlled trials (RCTs) on GC and GEJC up to December 2019. Additionally, we updated the literature search from Jan, 1, 2020 to September 30, 2021. Narrative and quantitative analysis were performed to analyse the efficacy and safety. STATA 15.1 was used to identify publication bias, and the SUCRA (surface under the cumulative ranking) curve was conducted to rank the treatments for each outcome. RESULTS: A total of 27 RCTs with 9295 GC and GEJC patients treated by 19 drugs were included. SUCRA showed that regorafenib was the most likely to improve patients' progression-free survival (96.4%), followed by apatinib (90.7%), nivolumab (82.4%), everolimus (76.5%) and pertuzumab (68.5%). Meanwhile, apatinib (92.4%) was most likely to improve overall survival, followed by nivolumab (87.9%), regorafenib (72.5%), olaparib (67.7%) and lapatinib (63.2%). Additionally, neutropenia, diarrhoea and fatigue were the most common adverse events caused by these drugs, followed by pain, nausea, decreased appetite, anaemia and vomiting. WHAT IS NEW AND CONCLUSION: Regorafenib and nivolumab have higher efficacy and tolerability and are the most advantageous for advanced GC and GEJC. Moreover, apatinib has higher efficacy but lower tolerability. Everolimus and pertuzumab combined with chemotherapy have best secondary higher efficacy for progression-free survival and good tolerability. Lapatinib and olaparib combined with chemotherapy have moderate efficacy for overall survival and good tolerability.

Lubricant for reducing perineal trauma: A systematic review and meta-analysis of randomized controlled trials.

AIM: To assess the effect of lubricants on reducing perineal trauma during vaginal delivery. METHODS: PubMed, Embase, the Cochrane Library, CINAHL, China National Knowledge Infrastructure, China Biology Medicine disc, WanFang databases, and ClinicalTrials.gov, were searched for literature up to 25 June 2021. Randomized controlled trials published in English or Chinese that compared the vaginal application of lubricant with standard care for women were included. Two reviewers independently performed study screening, data extraction, risk of bias assessment, and certainty of evidence assessment. Pooled effect sizes and corresponding 95% confidence intervals (CI) were calculated using meta-analysis. RESULTS: Nineteen trials enrolling 5445 pregnant women were included. Compared with standard care, women using lubricants had a lower incidence of perineal trauma (risk ratio [RR] 0.84, 95% CI 0.76-0.93; low certainty evidence), second-degree perineal laceration (RR 0.72, 95% CI 0.64-0.82; moderate certainty evidence) and episiotomy (RR 0.77, 95% CI 0.62-0.96; very low certainty evidence), and had a shorter duration of the second-stage labor (MD -13.72 min, 95% CI -22.68 to -4.77; very low certainty evidence). CONCLUSION: Lubricants might reduce the incidence of perineal trauma, especially second-degree perineal laceration, and shorten the duration of the second-stage labor. More well-designed studies will continue developing high-quality evidence in this field.

Improving WHO's understanding of WHO guideline uptake and use in Member States: a scoping review.

BACKGROUND: WHO publishes public health and clinical guidelines to guide Member States in achieving better health outcomes. Furthermore, WHO's Thirteenth General Programme of Work for 2019-2023 prioritizes strengthening its normative functional role and uptake of normative and standard-setting products, including guidelines at the country level. Therefore, understanding WHO guideline uptake by the Member States, particularly the low- and middle-income countries (LMICs), is of utmost importance for the organization and scholarship. METHODS: We conducted a scoping review using a comprehensive search strategy to include published literature in English between 2007 and 2020. The review was conducted between May and June 2021. We searched five electronic databases including CINAHL, the Cochrane Library, PubMed, Embase and Scopus. We also searched Google Scholar as a supplementary source. The review adhered to the PRISMA-ScR (PRISMA extension for scoping reviews) guidelines for reporting the searches, screening and identification of evaluation studies from the literature. A narrative synthesis of the evidence around key barriers and challenges for WHO guideline uptake in LMICs is thematically presented. RESULTS: The scoping review included 48 studies, and the findings were categorized into four themes: (1) lack of national legislation, regulations and policy coherence, (2) inadequate experience, expertise and training of healthcare providers for guideline uptake, (3) funding limitations for guideline uptake and use, and (4) inadequate healthcare infrastructure for guideline compliance. These challenges were situated in the Member States' health systems. The findings suggest that governance was often weak within the existing health systems amongst most of the LMICs studied, as was the guidance provided by WHO's guidelines on governance requirements. This challenge was further exacerbated by a lack of accountability and transparency mechanisms for uptake and implementation of guidelines. In addition, the WHO guidelines themselves were either unclear and were technically challenging for some health conditions; however, WHO guidelines were primarily used as a reference by Member States when they developed their national guidelines. CONCLUSIONS: The challenges identified reflect the national health systems' (in)ability to allocate, implement and monitor the guidelines. Historically this is beyond the remit of WHO, but Member States could benefit from WHO implementation guidance on requirements and needs for successful uptake and use of WHO guidelines.

[Proposal of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19].

In order to standardize the clinical diagnosis and treatment decision-making with traditional Chinese medicine for pa-tients of coronavirus disease 2019(COVID-19) and put the latest clinical study evidence into clinical practice, the international trust-worthy traditional Chinese medicine recommendations( TCM Recs) working group started the compilation of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 on the basis of the standards and re-quirements of WHO handbook, GRADE and RIGHT. This proposal mainly introduces the formulation methods and processes of the living guidelines in details, such as the composition of the working group, the collection and identification of clinical issues and out-comes, the production of the living systematic review and the consensus of recommendations. The guidelines will continue to monitor the clinical study evidences of TCM in the prevention and treatment of COVID-19, and conduct regular evidence updating, retrieval and screening. When there is new study evidence, the steering committee will evaluate the possibility of the evidence to change clinical practice or previous recommendations, so as to decide whether the recommendations for the guidelines shall be implemented or upda-ted. The main criteria considered in the guideline updating are as follows:(1) There are new high-quality randomized controlled trial(RCT) evidences for TCM uninvolved in the previous edition of the guidelines;(2) as for the TCM involved in the guidelines, living sys-tematic review shows that new evidence may change the direction or strength of the existing recommendations. The specific implementation of the living evidence-based guidelines will take this proposal as the study basis and framework, in order to ensure the standardization of the formulation process and methods. This will be the first exploration of the methodology for living guidelines in the field of TCM.

Effectiveness of dignity therapy for patients with advanced cancer: A systematic review and meta-analysis of 10 randomized controlled trials.

BACKGROUND: Dignity is a vitally important aspect of the lives of advanced cancer patients. We conducted a systematic review and meta-analysis of the effectiveness of dignity therapy in this patient population. METHODS: We searched for randomized controlled trials comparing dignity therapy versus standard care for patients with advanced cancer in five comprehensive databases (March 2019), two clinical trial registries and one gray literature database (August 2019). The quality of the studies was assessed using the risk of bias tool recommended by the Cochrane Handbook Version 5.1.0. We used GRADE approach to assess the certainty of evidence. Meta-analysis was performed with RevMan version 5.3. Outcomes of interest included anxiety, depression, dignity-related distress and quality of life (QoL). RESULTS: Ten trials evaluating 904 patients (control, 449; experimental, 455) were identified. Six trials included patients with different types of advanced cancer, and four trials included patients with a single advanced cancer (lung cancer [20%], breast cancer [10%], and hepatocellular carcinoma [10%]). Compared with the standard care, dignity therapy decreased the score of anxiety, depression, and dignity-related distress of the advanced cancer patients (SMD = -1.07, 95% CI: [-1.57, -0.58], p < .05; SMD = -1.31, 95% CI: [-1.92, -0.70], p < .05; MD = -7.30, 95% CI: [- 12.04, - 2.56], p < .05). In addition, no significant differences were found in the patient's QoL (p > .05). CONCLUSION: Very low certainty evidence demonstrated that dignity therapy might be a promising treatment, especially in reducing anxiety and depression in advanced cancer patients.

Assessing the Risk of Bias in Randomized Clinical Trials With Large Language Models.

Importance: Large language models (LLMs) may facilitate the labor-intensive process of systematic reviews. However, the exact methods and reliability remain uncertain. Objective: To explore the feasibility and reliability of using LLMs to assess risk of bias (ROB) in randomized clinical trials (RCTs). Design, Setting, and Participants: A survey study was conducted between August 10, 2023, and October 30, 2023. Thirty RCTs were selected from published systematic reviews. Main Outcomes and Measures: A structured prompt was developed to guide ChatGPT (LLM 1) and Claude (LLM 2) in assessing the ROB in these RCTs using a modified version of the Cochrane ROB tool developed by the CLARITY group at McMaster University. Each RCT was assessed twice by both models, and the results were documented. The results were compared with an assessment by 3 experts, which was considered a criterion standard. Correct assessment rates, sensitivity, specificity, and F1 scores were calculated to reflect accuracy, both overall and for each domain of the Cochrane ROB tool; consistent assessment rates and Cohen κ were calculated to gauge consistency; and assessment time was calculated to measure efficiency. Performance between the 2 models was compared using risk differences. Results: Both models demonstrated high correct assessment rates. LLM 1 reached a mean correct assessment rate of 84.5% (95% CI, 81.5%-87.3%), and LLM 2 reached a significantly higher rate of 89.5% (95% CI, 87.0%-91.8%). The risk difference between the 2 models was 0.05 (95% CI, 0.01-0.09). In most domains, domain-specific correct rates were around 80% to 90%; however, sensitivity below 0.80 was observed in domains 1 (random sequence generation), 2 (allocation concealment), and 6 (other concerns). Domains 4 (missing outcome data), 5 (selective outcome reporting), and 6 had F1 scores below 0.50. The consistent rates between the 2 assessments were 84.0% for LLM 1 and 87.3% for LLM 2. LLM 1's κ exceeded 0.80 in 7 and LLM 2's in 8 domains. The mean (SD) time needed for assessment was 77 (16) seconds for LLM 1 and 53 (12) seconds for LLM 2. Conclusions: In this survey study of applying LLMs for ROB assessment, LLM 1 and LLM 2 demonstrated substantial accuracy and consistency in evaluating RCTs, suggesting their potential as supportive tools in systematic review processes.

PROTOCOL: Assessment of publication time in Campbell systematic reviews: A cross-sectional survey.

This is the protocol for a Campbell systematic review. The objectives are as follows. This study has three main objectives: (1) To examine the time duration from title registration to publication of the protocol for a Campbell systematic review and publication of the completed Campbell systematic review; (2) To describe publication times in accordance with the characteristics of the reviews, which include year of publication, type of review, number of authors, number of collaborative institutions, the time gap between the date the search was conducted and review publication, and the length and complexity of the included review (including the number of pages, the number of tables and figures, the number of studies included in the review, the number and type of analyses undertaken, and the number of references); (3) To describe the differences in publication times between Campbell Review Groups.

Effectiveness of Multicomponent Interventions in Office-Based Workers to Mitigate Occupational Sedentary Behavior: Systematic Review and Meta-Analysis.

BACKGROUND: Sedentary time in workplaces has been linked to increased risks of chronic occupational diseases, obesity, and overall mortality. Currently, there is a burgeoning research interest in the implementation of multicomponent interventions aimed at decreasing sedentary time among office workers, which encompass a comprehensive amalgamation of individual, organizational, and environmental strategies. OBJECTIVE: This meta-analysis aims at evaluating the effectiveness of multicomponent interventions to mitigate occupational sedentary behavior at work compared with no intervention. METHODS: PubMed, Web of Science, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched from database inception until March 2023 to obtain randomized controlled trials (RCTs) assessing the efficacy of multicomponent interventions on occupational sedentary behavior among office-based workers. Two reviewers independently extracted the data and assessed the risk of bias by using the Cochrane Collaboration's risk of bias tool. The average intervention effect on sedentary time was calculated using Stata 15.1. Mean differences (MDs) with 95% CIs were used to calculate the continuous variables. Subgroup analyses were performed to determine whether sit-stand workstation, feedback, and prompt elements played an important role in multicomponent interventions. Further, the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system was used to evaluate the certainty of evidence. RESULTS: A total of 11 RCTs involving 1894 patients were included in the analysis. Five studies were rated as low risk of bias, 2 as unclear risk of bias, and 4 as high risk. The meta-analysis results showed that compared with no intervention, multicomponent interventions significantly reduced occupational sitting time (MD=-52.25 min/8-h workday, 95% CI -73.06 to -31.44; P<.001) and occupational prolonged sitting time (MD=-32.63 min/8-h workday, 95% CI -51.93 to -13.33; P=.001) and increased occupational standing time (MD=44.30 min/8-h workday, 95% CI 23.11-65.48; P<.001), whereas no significant differences were found in occupational stepping time (P=.06). The results of subgroup analysis showed that compared with multicomponent interventions without installment of sit-stand workstations, multicomponent interventions with sit-stand workstation installment showed better effects for reducing occupational sitting time (MD=-71.95 min/8-h workday, 95% CI -92.94 to -51.15), increasing occupational standing time (MD=66.56 min/8-h workday, 95% CI 43.45-89.67), and reducing occupational prolonged sitting time (MD=-47.05 min/8-h workday, 95% CI -73.66 to -20.43). The GRADE evidence summary showed that all 4 outcomes were rated as moderate certainty. CONCLUSIONS: Multicomponent interventions, particularly those incorporating sit-stand workstations for all participants, are effective at reducing workplace sedentary time. However, given their cost, further research is needed to understand the effectiveness of low-cost/no-cost multicomponent interventions.

Diagnostic accuracy of the 4AT for delirium: A systematic review and meta-analysis.

INTRODUCTION: Despite common, serious, costly, and often fatal conditions affecting up to 50 % of older patients, delirium is often unrecognized and overlooked. We examine the accuracy of the 4AT for detecting older patients with delirium. METHODS: We performed a systematic search of PubMed, Web of Science, PsycINFO, and EMBASE databases from inception to April 2020 and updated to January 2022. Four independently reviewers extracted study data and assessed the methodological quality using the revised quality assessment of diagnostic accuracy studies tool (QUADAS-2). Pooled estimates of sensitivity and specificity were generated using a bivariate random effects model. All statistical analyses were performed with STATA version 15.1 and Meta-DiSc version 1.4 software. RESULTS: Eleven studies with 2789 participants were included. The pooled sensitivity and specificity were 0.87 (95 % CI: 0.81-0.91) and 0.87 (95 % CI: 0.79-0.92), respectively, and the positive and negative likelihood ratios were 6.66 (95 % CI: 4.12-10.74) and 0.15 (95 % CI: 0.10-0.23), respectively. Deeks' test indicated no significant publication bias (t = 0.83, P = 0.43). Univariable meta-regression showed that patient selection and flow and timing significantly influenced the pooled sensitivity (P < 0.05), settings significantly influenced the pooled specificity (P < 0.05). CONCLUSION: Our meta-analysis demonstrates that 4AT is a sensitive and specific screening tool for delirium in older patients. Its brevity and simplicity support its use in routine clinical practice, particularly in time-poor settings. Clinicians should come to a conclusion based largely on the 4AT findings in conjunction with clinical judgment.

Nutritional Recommendations for Type 2 Diabetes: An International Review of 15 Guidelines.

OBJECTIVES: Recommendations from clinical practice guidelines (CPGs) for individuals with type 2 diabetes mellitus (T2DM) may be inconsistent, and little is known about their quality. Our aim in this study was to systematically review the consistency of globally available CPGs containing nutritional recommendations for T2DM and to assess the quality of their methodology and reporting. METHODS: PubMed, China Biology Medicine and 4 main guideline websites were searched. Four researchers independently assessed quality of the methodology and reporting using the Appraisal of Guidelines for Research and Evaluation, second edition (AGREE II) instrument and the Reporting Items for Practice Guidelines in HealThcare (RIGHT) checklist. RESULTS: Fifteen CPGs include 65 nutritional recommendations with 6 sections: 1) body weight and energy balance; 2) dietary eating patterns; 3) macronutrients; 4) micronutrients and supplements; 5) alcohol; and 6) specific, functional foods. Current nutritional recommendations for individuals with T2DM on specific elements and amounts are not completely consistent in different CPGs and fail to assign the specific supporting evidence and strength of recommendations. To use nutritional recommendations to guide and manage individuals with T2DM, it is important to address the current challenges by establishing a solid evidence base and indicating the strength of recommendations. Overall, 8 CPGs classified as recommended for clinical practice used AGREE II. Fifteen CPGs adhere to <60% of RIGHT checklist items. CONCLUSIONS: High-quality evidence is needed to potentially close knowledge gaps and strengthen the recommendation. The AGREE II instrument, along with the RIGHT checklist, should be endorsed and used by CPG developers to ensure higher quality and adequate use of their products.

Cognitive behavioural therapy for functional abdominal pain disorders in children and adolescents: A systematic review of randomized controlled trials.

AIM: Although Cognitive behavioural therapy (CBT) potentially holds efficacy in addressing functional abdominal pain disorders (FAPDs) amongst children and adolescents, the persistent efficacy is uncertain. METHODS: We searched three databases to identify related randomized controlled trials (RCTs). Meta-analysis was performed using RevMan and Stata. Subgroup analyses were mainly conducted based on follow-up time. The GRADE approach was used to evaluate the certainty of the evidence. RESULTS: A total of 14 RCTs evaluating 858 patients were included. All RCTs were rated as having a high risk of bias. Compared with control groups, CBT was associated with improvement of general functional impairment (standardized mean difference (SMD) = -0.77, 95% CI [-1.12, -0.42], p < 0.05), higher treatment success (relative risk (RR) = 2.35, 95% CI [1.50, 3.69], p < 0.05), improvement of abdominal pain symptoms (SMD = -0.48, 95% CI [-0.73, -0.23], p < 0.05), QoL (SMD = 0.42, 95% CI [0.20, 0.64], p < 0.05), and psychological states (SMD = -0.95, 95% CI [-1.62, -0.27], p < 0.05). CONCLUSION: This meta-analysis provides low to moderate quality evidence that CBT could significantly improve clinical outcomes and QoL for children and adolescents with FAPDs with improvement persisting until short-term follow-up. However, there were discrepancies regarding CBT's effects at mid- and long-term follow-up across different outcomes. More high-quality and longer-duration studies are thus warranted to explore the effectiveness of CBT in the future. SYSTEMATIC REVIEW REGISTRATION ON PROSPERO: CRD42022369353.

The Comparative Effectiveness and Safety of Insomnia Drugs: A Systematic Review and Network Meta-Analysis of 153 Randomized Trials.

BACKGROUND: Pharmacological treatment is common in practice and widely used for the management of insomnia. However, evidence comparing the relative effectiveness, safety, and certainty of evidence among drug classes and individual drugs for insomnia are still lacking. This study aimed to determine the relative effectiveness, safety, and tolerability of drugs for insomnia. METHODS: In this systematic review and network meta-analysis we systematically searched PubMed, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, and ClinicalTrials.gov, from inception to January 10, 2022 to identify randomized controlled trials that compared insomnia drugs with placebo or an active comparator in adults with insomnia. We conducted random-effects frequentist network meta-analyses to summarize the evidence, and used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to assess the certainty, categorize interventionsand present the findings. RESULTS: A total of 148 articles met our eligibility criteria; these included 153 trials which enrolled 46,412 participants and assessed 36 individual drugs from eight drug classes. Compared with placebo, both subjectively and objectively measured total sleep time were significantly improved with non-benzodiazepine (subjective: mean difference [MD] 25.07, 95% confidence interval [CI] 15.49-34.64, low certainty; objective: MD 22.34, 95% CI 7.64-37.05, high certainty), antidepressants (subjective: MD 54.40, 95% CI 34.96-75.83, low certainty; objective: MD 35.64, 95% CI 13.05-58.24, high certainty), and orexin receptor antagonists (subjective: MD 21.62, 95% CI 0.84-42.40, high certainty; objective: MD 31.81, 95% CI 2.66-60.95, high certainty); of which doxepin, almorexant, suvorexant, and lemborexant were among the relatively effective drugs with relatively good tolerability and lower risks of any adverse events (AEs). Both subjectively and objectively measured sleep onset latency were significantly shortened with non-benzodiazepines (subjective: MD - 10.12, 95% CI - 13.84 to - 6.40, moderate certainty; objective: MD - 12.11, 95% CI - 19.31 to - 4.90, moderate certainty) and melatonin receptor agonists (subjective: MD - 7.73, 95% CI - 15.21 to - 0.26, high certainty; objective: MD - 7.04, 95% CI - 12.12 to - 1.95, moderate certainty); in particular, zopiclone was among the most effective drugs with a lower risk of any AEs but worse tolerability. Non-benzodiazepines could significantly decrease both subjective and objective measured wake time after sleep onset (subjective: MD - 16.67, 95% CI - 21.79 to - 11.56, moderate certainty; objective: MD - 13.92, 95% CI - 22.71 to - 5.14, moderate certainty). CONCLUSIONS: Non-benzodiazepines probably improve total sleep time, sleep onset latency, and wake time after sleep onset. Other insomnia drug classes and individual drugs also showed potential benefits in improving insomnia symptoms. However, the choice of insomnia drugs should be based on the phenotype of insomnia presented, as well as each drug's safety and tolerability. Protocol registration PROSPERO (CRD42019138790).

How do network meta-analyses address intransitivity when assessing certainty of evidence: a systematic survey.

OBJECTIVES: To describe how systematic reviews with network meta-analyses (NMAs) that used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) NMA approach addressed intransitivity when assessing certainty of evidence. DESIGN: Systematic survey. DATA SOURCES: Medline, Embase and Cochrane Database of Systematic Reviews from September 2014 to October 2022. ELIGIBILITY CRITERIA: Systematic reviews of randomised controlled trials with aggregate data NMAs that used the GRADE NMA approach for assessing certainty of evidence. DATA EXTRACTION AND SYNTHESIS: We documented how reviewers described methods for addressing intransitivity when assessing certainty of evidence, how often they rated down for intransitivity and their explanations for rating down. RESULTS: Of the 268 eligible systematic reviews, 44.8% (120/268) mentioned intransitivity when describing methods for assessing the certainty of evidence. Of these, 28.3% (34/120) considered effect modifiers and from this subset, 67.6% (23/34) specified the effect modifiers; however, no systematic review noted how they chose the effect modifiers. 15.0% (18/120) mentioned looking for differences between the direct comparisons that inform the indirect estimate. No review specified a threshold for difference in effect modifiers between the direct comparisons that would lead to rating down for intransitivity. Reviewers noted rating down indirect evidence for intransitivity in 33.1% of systematic reviews, and noted intransitivity for network estimates in 23.0% of reviews. Authors provided an explanation for rating down for intransitivity in 59.6% (31/52) of the cases in which they rated down. Of the 31 in which they provided an explanation, 74.2% (23/31) noted they detected differences in effect modifiers and 67.7% (21/31) specified in what effect modifiers they detected differences. CONCLUSIONS: A third of systematic reviews with NMAs using the GRADE approach rated down for intransitivity. Limitations in reporting of methods to address intransitivity proved considerable. Whether the problem is that reviewers neglected to address rating down for transitivity at all, or whether they did consider but not report, is not clear. At minimum systematic reviews with NMAs need to improve their reporting practices regarding intransitivity; it may well be that they need to improve their practice in transitivity assessment. How to best address intransitivity may remain unclear for many reviewers thus additional GRADE guidance providing practical instructions for addressing intransitivity may be desirable.

Use of traditional Chinese medicine for the treatment and prevention of COVID-19 and rehabilitation of COVID-19 patients: An evidence mapping study.

Background: The potential effectiveness of traditional Chinese medicine (TCM) against "epidemic diseases" has highlighted the knowledge gaps associated with TCM in COVID-19 management. This study aimed to map the matrix for rigorously assessing, organizing, and presenting evidence relevant to TCM in COVID-19 management. Methods: In this study, we used the methodology of evidence mapping (EM). Nine electronic databases, the WHO International Clinical Trials Registry Platform (ICTRP) Search Portal, ClinicalTrials.gov, gray literature, reference lists of articles, and relevant Chinese conference proceedings, were searched for articles published until 23 March 2022. The EndNote X9, Rayyan, EPPI, and R software were used for data entry and management. Results: In all, 126 studies, including 76 randomized controlled trials (RCTs) and 50 systematic reviews (SRs), met our inclusion criteria. Of these, only nine studies (7.14%) were designated as high quality: four RCTs were assessed as "low risk of bias" and five SRs as "high quality." Based on the research objectives of these studies, the included studies were classified into treatment (53 RCTs and 50 SRs, 81.75%), rehabilitation (20 RCTs, 15.87%), and prevention (3 RCTs, 2.38%) groups. A total of 76 RCTs included 59 intervention categories and 57 efficacy outcomes. All relevant trials consistently demonstrated that TCM significantly improved 22 outcomes (i.e., consistent positive outcomes) without significantly affecting four (i.e., consistent negative outcomes). Further, 50 SRs included nine intervention categories and 27 efficacy outcomes, two of which reported consistent positive outcomes and two reported consistent negative outcomes. Moreover, 45 RCTs and 38 SRs investigated adverse events; 39 RCTs and 30 SRs showed no serious adverse events or significant differences between groups. Conclusion: This study provides evidence matrix mapping of TCM against COVID-19, demonstrating the potential efficacy and safety of TCM in the treatment and prevention of COVID-19 and rehabilitation of COVID-19 patients, and also addresses evidence gaps. Given the limited number and poor quality of available studies and potential concerns regarding the applicability of the current clinical evaluation standards to TCM, the effect of specific interventions on individual outcomes needs further evaluation.

Methodological quality in guidelines for enhanced recovery after surgery was suboptimal.

OBJECTIVE: We aimed to appraise the methodological quality of existing guidelines for Enhanced Recovery After Surgery (ERAS) using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument and to identify the concordance of different recommendations. STUDY DESIGN AND SETTING: PubMed, Embase, Google Scholar, Web of Science, and clinical practice guideline websites were systematically searched. Four reviewers independently assessed the guidelines using the AGREE II instrument. The mean score of each AGREE II item, number of recommendations, strength of recommendation, and level of evidence were calculated. Agreement among reviewers was assessed using the intraclass correlation coefficient. RESULTS: We identified 23 guidelines from 7,127 records. The overall agreement among reviewers was considered good (intraclass correlation coefficient, 0.92; 95% confidence interval [CI], 0.86-0.96). The mean scores of the six AGREE domains were scope and purpose, 60.1% (95% CI, 55.9-64.1); stakeholder involvement, 40.7% (95% CI, 35.4-46.0); rigor of development, 44.7% (95% CI, 42.2-47.2); clarity and presentation, 69.8% (95% CI, 65.3-74.3); applicability, 37.2% (95% CI, 31.8-42.6); and editorial independence, 47.8% (95% CI, 39.0-56.7). Only 2/23 ERAS guidelines were considered applicable without modifications. CONCLUSIONS: The methodological quality of the ERAS management guidelines varied and was generally low. Future guideline development should adhere to the use of the AGREE II instrument and the GRADE system to better guide clinical practice and improve individualized treatment strategies.

Risk of abnormal pregnancy outcomes after using ondansetron during pregnancy: A systematic review and meta-analysis.

Background: Hyperemesis gravidarum is a serious pregnancy complication that affects approximately 1% of pregnancies worldwide. Objective: To determine whether the use of ondansetron during pregnancy is associated with abnormal pregnancy outcomes. Search strategy: PubMed, Cochrane Library, CINAHL, Embase, CNKI, CBM, WANFANG, and ClinicalTrials.gov were searched for citations published in any language from inception to 15 December 2021. Selection criteria: Eligible studies included any observational study. Data collection and analysis: Odds ratio (OR) and 95% confidence interval (CI) were used as indicators to examine the association between ondansetron and abnormal pregnancy outcomes. Main results: Twenty articles from 1,558 citations were included. Our preliminary analysis showed that compared with the unexposed group, the use of ondansetron during pregnancy may be associated with an increased incidence of cardiac defects (OR = 1.06, 95% CI: 1.01-1.10), neural tube defects (OR = 1.12, 95% CI: 1.05-1.18), and chest cleft (OR = 1.21, 95% CI: 1.07-1.37). Further sensitivity analysis showed no significant association between ondansetron and cardiac defects (OR = 1.15,95% CI: 0.94-1.40) or neural tube defects (OR = 0.87,95% CI: 0.46-1.66). When controversial studies were eliminated, the results for the chest defects disappeared. Simultaneously, we found that the use of ondansetron was associated with a reduced incidence of miscarriage (OR = 0.53, 95% CI: 0.31-0.89). Ondansetron was not associated with orofacial clefts (OR = 1.09,95% CI: 0.95-1.25), spinal limb defects (OR = 1.14,95% CI: 0.89-1.46), urinary tract deformities (OR = 1.06,95% CI: 0.97-1.15), any congenital malformations (OR = 1.03,95% CI: 0.98-1.09), stillbirth (OR = 0.97,95% CI: 0.83-1.15), preterm birth (OR = 1.22,95% CI: 0.80-1.85), neonatal asphyxia (OR = 1.05,95% CI: 0.72-1.54), or neonatal development (OR = 1.18,95% CI: 0.96-1.44) in our primary analysis. Conclusion: In our analysis, using ondansetron during pregnancy was not associated with abnormal pregnancy outcomes. Although our study did not find sufficient evidence of ondansetron and adverse pregnancy outcomes, future studies including the exposure period and dose of ondansetron, as well as controlling for disease status, may be useful to truly elucidate the potential risks and benefits of ondansetron.